UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021325 |
|---|---|
| Receipt number | R000024138 |
| Scientific Title | Cytoreductive surgery combined with perioperative intraperitoneal chemotherapy for peritoneal metastasis from colorectal or appendiceal cancer: a feasibility study |
| Date of disclosure of the study information | 2016/03/03 |
| Last modified on | 2019/08/13 19:46:08 |
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Basic information
Public title
Cytoreductive surgery combined with perioperative intraperitoneal chemotherapy
for peritoneal metastasis from colorectal or appendiceal cancer: a feasibility study
Acronym
Cytoreductive surgery combined with perioperative intraperitoneal chemotherapy
for peritoneal metastasis from colorectal or appendiceal cancer: a feasibility study
Scientific Title
Cytoreductive surgery combined with perioperative intraperitoneal chemotherapy
for peritoneal metastasis from colorectal or appendiceal cancer: a feasibility study
Scientific Title:Acronym
Cytoreductive surgery combined with perioperative intraperitoneal chemotherapy
for peritoneal metastasis from colorectal or appendiceal cancer: a feasibility study
Region
| Japan |
Condition
Condition
Peritoneal metastasis from colorectal or appendiceal cancer
Classification by specialty
| Hematology and clinical oncology | Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility and safety of cytoreductive surgery combined with perioperative intraperitoneal chemotherapy
for peritoneal metastasis from colorectal or appendiceal cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
safety
Key secondary outcomes
1-year overall survival rate
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Cytoreductive surgery (CRS), Hyperthermic intraperitoneal chemotherapy (HIPEC), Early postoperative intraperitoneal chemotherapy (EPIC)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Histologically proven colon or appendiceal cancer; peritoneal metastasis; age between 20 and 80 years; Synchronous or metachronous metastasis; Eastern Cooperative Oncology Group performance status 0-1; adequate bone marrow function ; and borderline resectable distant metastasis
Key exclusion criteria
1) Patient who has a history of multiple cancers within 5 years before registration, with the exception of carcinoma in situ and a disease equivalent to intramucosal carcinoma.
2) Patient who is associated with unstable angina pectoris that occurred or worsened within 3 weeks before registration, or patient with a history of cardiac infarction that developed within 6 months before registration.
3) Patient with serious diseases including uncontrolled congestive cardiac failure and abnormal cardiac rhythm.
4) Patient who is associated with or has a history of either fibroid lung or interstitial pneumonia or both. Patient with imaging findings suggestive of the diseases.
5) Patient who is pregnant or breast feeding, or who refuses to use appropriate birth control.
6) Patient whose consent is suspicious in terms of his/her mental and legal state.
7) Patient who is considered by the investigator to be unsuitable for enrollment.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Tomomichi |
| Middle name | |
| Last name | Kiyomatsu |
Organization
National Center for Global Health and Medicine
Division name
Department of Surgery
Zip code
162-8655
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan
TEL
03-3202-7181
tkiyomatsu@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Yoshimasa |
| Middle name | |
| Last name | Gohda |
Organization
National Center for Global Health and Medicine
Division name
Department of Surgery
Zip code
162-8655
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan
TEL
03-3202-7181
Homepage URL
ygohda@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Global Helth and Medicine
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo
Tel
0332027181
rinrijm@hosp.ncgm.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 03 | Day |
Last modified on
| 2019 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024138
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
